# FDA 483 - Generichem Corporation - June 08, 2022

Source: https://www.keypedia.com/records/483/generichem-corporation/9769e74f-20f6-4e28-94b1-88a61170b08e

> FDA 483 for Generichem Corporation on June 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Generichem Corporation
- Inspection Date: 2022-06-08
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Generichem Corporation, a labeler/relabeler in Totowa, NJ, revealed significant deficiencies in its quality control unit and investigation procedures. The firm failed to establish written responsibilities with its API manufacturer and did not adequately document customer inquiries or investigations into product discrepancies. These findings indicate a lack of robust quality management practices.

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)
- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/generichem-corporation/5765ea81-03b8-4c8e-9ee2-f6af68a2c44e

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248